[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520182":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":39,"locations":45,"responsibleParty":69,"collaborators":33,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":33,"studyType":85,"phases":86,"briefSummary":89,"conditions":90,"keywords":33,"overallStatus":48,"whyStopped":33,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Creative Medical Technology Holdings Inc","INDUSTRY",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Low Dose","EXPERIMENTAL","Subjects in the low dose arm will receive a single administration of either 6x10\\^6 cells (n=8) or a placebo injection (n=2). Each subject will receive six paraspinal intramuscular injections (three injections per side) of either CELZ-201-DDT or placebo into the lumbar musculature under direct ultrasound guidance.",[13,14],"Drug: CELZ-201-DDT","Other: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Medium Dose","Subjects in the medium dose arm will receive a single administration of either 30x10\\^6 cells (n=8) or a placebo injection (n=2). Each subject will receive six paraspinal intramuscular injections (three injections per side) of either CELZ-201-DDT or placebo into the lumbar musculature under direct ultrasound guidance.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"High Dose","Subjects in the high dose arm will receive a single administration of either 60x10\\^6 cells (n=8) or a placebo injection (n=2). Each subject will receive six paraspinal intramuscular injections (three injections per side) of either CELZ-201-DDT or placebo into the lumbar musculature under direct ultrasound guidance.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Expanded High Dose","Subjects in the expanded high dose arm will receive a single administration of either 120x10\\^6 cells (n=10) or a placebo injection (n=5). Each subject will receive six paraspinal intramuscular injections (three injections per side) of either CELZ-201-DDT or placebo into the lumbar musculature under direct ultrasound guidance.",[13,14],[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","CELZ-201-DDT","Subjects enrolled in the trial will receive CELZ-201-DDT at the specified dose into the lumbar paraspinal musculature. Each subject will receive a total of six injections, three injections on each side, under direct ultrasound guidance.",[24,20,9,16],null,{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":33},"OTHER","Placebo","Subjects will receive a placbeo injection into the lumbar paraspinal musculature. Each subject will receive a total of six injections, three injections on each side, under direct ultrasound guidance.",[24,20,9,16],[40],{"name":41,"role":42,"phone":43,"phoneExt":33,"email":44},"Creative Medical Technology","CONTACT","(702) 588-1890","clinicaltrials@creativemedicaltechnology.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Spine and Wellness Centers of America","RECRUITING","Aventura","Florida","33180","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-80.13921,25.95648,{"lat":58,"lon":57},[61,64,66],{"name":62,"role":42,"phone":63,"phoneExt":33,"email":33},"Christian Gonzalez, MD","(305) 974-5533",{"name":62,"role":65,"phone":33,"phoneExt":33,"email":33},"PRINCIPAL_INVESTIGATOR",{"name":67,"role":68,"phone":33,"phoneExt":33,"email":33},"Gina Corsaletti, MD","SUB_INVESTIGATOR",{"type":70,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100520182","phase-1-safety-tolerability-and-effectiveness-of-intramuscular-injection-of-celz-201-ddt-for-the-treatment-of-chronic-lower-back-pain-100520182",false,"NCT06053242","Safety, Tolerability, and Effectiveness of Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain","A Double-blinded, Randomized, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Effectiveness of CELZ-201-DDT Administered by Intramuscular Injection for the Treatment of Chronic Lower Back Pain in Patients With Degenerative Disc Disease","ADAPT","Inclusion Criteria:\n\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n* Between 18-80 years of age and may be of either gender or any race.\n* Subjects must have failed at least two standard of care (SOC) therapies before being enrolled in the study: 1) exercise\u002Fphysical therapy; 2) oral analgesic including nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen; 3) skeletal muscle relaxants. Subjects must have tried each SOC therapy for at least 3 months before failure is determined.\n* Patients must have failed the SOC therapies within 12 months of enrollment in the clinical trial.\n* Proof for one of the following tests already performed in the clinical care of the patient for lower back pain: 1) MRI scan demonstrating at least one disc level with grade II or greater disc degeneration using the Pfirrmann grading system; 2) Oswestry Disability Index for Back Pain score of 21-80%; 3) Visual Analogue Scale for pain of \\>5 on a scale of 0-10.\n* Female subjects must not be breast feeding and must have no intention to become pregnant during the study, and she is using contraceptive drugs or devices.\n* Any male subject must agree to use contraceptives and not donate sperm during the study.\n* Subjects may be on stable opioids, narcotics, or muscle relaxants for ≥30 days before screening.\n\nExclusion Criteria:\n\n* History of cancer in the last five years.\n* Spinal infections and spinal tumors.\n* Renal insufficiency requiring dialysis or an eGFR of less than 60 mL\u002Fmin\u002F1.73m2.\n* ALT, AST greater than 2 times or Total Bilirubin 1.5 times the upper limit of the normal range.\n* Positive pregnancy test.\n* History of blood cell diseases.\n* Uncontrolled diabetes mellitus - HgA1c \\>8%.\n* Uncontrolled hypertension defined as a systolic blood pressure of \\>140 mmHg or diastolic blood pressure of \\>90 mmHg at the time of screening. If subjects have their hypertension appropriately treated, then they would be eligible to enroll.\n* Patients known to have any active infection, including infection of the injection site(s), and\u002For any active systemic or local infection.\n* Patients on chronic immunosuppressive transplant therapy. Patients receiving \\\u003C5 mg of Prednisone daily may be included.\n* Subjects having a concomitant life-threatening disease in which their life expectancy is estimated to be less than 2 years.\n* Recent smoking history or substance abuse (within six weeks).\n* Heavy alcohol use (greater than 14 drinks per week for men or 7 drinks per week for women per NIAAA)\n* Use of an investigational drug, device or product, or participation in a drug research study within a period of 30 days prior to receiving study treatment.\n* Any patient who has received gene therapy in the past.\n* Subjects with an average baseline MED \\>90 mg\u002Fday during the screening period are excluded. The average will be calculated over a 7-day time period.\n* Body Mass Index (BMI) \\> 40 kg\u002Fm2.","ALL","18 Years","80 Years",{"count":83,"type":84},45,"ESTIMATED","INTERVENTIONAL",[87,88],"PHASE1","PHASE2","The brief purpose of this research study is to learn about the safety, tolerability, and efficacy of paraspinal intramuscular injection of CELZ-201-DDT in patients with chronic lower back pain.",[91,92],"Chronic Low-back Pain","Degenerative Disc Disease","2026-02-11",{"date":95,"type":96},"2026-02-13","ACTUAL",{"date":98,"type":96},"2024-05-21",{"date":100,"type":84},"2027-05-01",{"name":5,"class":6},1]